Evaluation of Community Health Worker Support to Help People With Serious Mental Illness to Quit Smoking

NCT07789132 | Not Yet Recruiting

• 1 other identifier: 2026P001847
• Study Type: interventional
• Target: 937
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn whether providing additional smoking cessation support through specially trained members of behavioral healthcare team helps people quit smoking and improve their health. Participants ages 18-75 who receive mental health services and smoke cigarettes every day may qualify for this study looking at new ways to help people quit smoking.

Conditions

Nicotine Dependance; Serious Mental Illness; Smoking (Tobacco) Addiction; Tobacco Cessation; Community Health Workers; Cardiovascular (CV) Risk; Tobacco Use Disorder

Keywords

nicotine dependence; serious mental illness; community health Workers; cardiovascular risk; tobacco treatment specialist; intensive case manager; tobacco use disorder

Outcome Measures

Primary Outcomes (2)

• Biochemically Verified 7-Day Point Prevalence Abstinence From Combusted Tobacco

  Number of participants with self-reported abstinence from combusted tobacco products for at least 7 days at the 18-month assessment, biochemically verified using salivary cotinine or expired carbon monoxide (CO). Abstinence will be verified by salivary cotinine \<30 ng/mL. For participants using nicotine replacement therapy (NRT) or e-cigarettes at the time of assessment, expired CO \<5 parts per million (ppm) will be used to verify abstinence from combusted tobacco.

  18 months

• Change in Estimated Cardiovascular Risk (ACC/AHA ASCVD Risk Estimator)

  Change in estimated 10-year risk of atherosclerotic cardiovascular disease (ASCVD) from baseline to 18 months, as calculated using the American College of Cardiology (ACC)/American Heart Association (AHA) ASCVD Risk Estimator based on: age, sex, race, blood pressure, smoking status, lipids (HDL and total cholesterol), diabetes diagnosis, HbA1c, antihypertension therapy. Lower estimated risk indicates improvement in cardiovascular risk.

  Baseline - 18 months

Secondary Outcomes (9)

• Change in Depressive Symptoms (PHQ-9)

  Baseline - 18 months

• Change in Anxiety Symptoms (GAD-7)

  Baseline - 18 months

• Change in Psychiatric Symptoms (Colorado Symptom Index)

  Baseline - 18 months

• Clinical Global Improvement

  Baseline - 18 months

• Change in Loneliness

  Baseline - 18 months

Study Arms (2)

Integrated CHW support intervention

EXPERIMENTAL

The randomization will be at the level of intensive care managers (ICM). Randomization will be stratified by care team. ICMs in this arm will be assigned to receive CHW and Tobacco Treatment Specialist certificate training (ICM-T) . Participants receive support from their ICM who has received CHW and TTS (ICM-T) training

Behavioral: Integrated CHW Support intervention

Enhanced usual care (EUC)

OTHER

The randomization will be at the level of intensive care managers (ICM). Randomization will be stratified by care team. ICMs in this arm (active-controlled) will not receive CHW and TTS training, participants will receive enhanced usual care (EUC) e.g. continue to receive ICM care.

Behavioral: Enhanced usual care (EUC)

Interventions

Integrated CHW Support intervention BEHAVIORAL

Participants assigned to the Integrated CHW Support intervention will receive smoking cessation support from their Intensive Case Manager (ICM), who has completed Community Health Worker (CHW) core competency training and Tobacco Treatment Specialist (TTS) certification. The intervention is integrated into routine case management and includes individualized smoking cessation counseling, education, motivational support, assistance with setting quit goals, facilitation of evidence-based tobacco treatment medications through participants' healthcare providers, coordination of healthcare services, accompaniment to medical appointments when appropriate, and support addressing social determinants of health that may affect tobacco cessation (e.g., housing, transportation, food insecurity, medication access). Participants will receive approximately four in-person or community-based contacts per month, supplemented by telephone or video contacts as needed, over a 18-month intervention period.

Integrated CHW support intervention

Enhanced usual care (EUC) BEHAVIORAL

Participants assigned to Enhanced Usual Care (EUC) will continue to receive standard behavioral health and case management services provided by their Intensive Case Manager (ICM). ICMs assigned to the EUC arm will not receive Community Health Worker (CHW) core competency training or Tobacco Treatment Specialist (TTS) certification and will not deliver the structured Integrated CHW Support intervention.

Enhanced usual care (EUC)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75, inclusive
• Have been diagnosed with SMI that has qualified them for Medicaid behavioral health services (i.e., mood, anxiety, traumatic, and psychotic disorders with or without functional impairment) and receive care through the community human services organizations in Massachusetts.
• Self-report of past year daily tobacco smoking
• Able to understand study procedures and communicate in English or Spanish
• Willingness to participate in a biannual interview with a research coordinator and to meet with a CHW if assigned to one
• Competent and willing to provide informed consent

You may not qualify if:

• Have dementia or intellectual disability (estimated IQ\< 70)
• Not able to communicate in English or Spanish
• Unstable medical condition that compromises ability to safely participate, in the investigator's opinion
• Evidence of active problem substance use severe enough to compromise ability to safely participate, in the investigator's opinion
• Unwilling to participate in study procedures
• Any condition or situation that would, in the investigator's opinion, make it unlikely that the participant could adhere safely to the study protocol

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Center for Addiction Medicine - Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (10)

• Evins AE, Cather C, Pratt SA, Pachas GN, Hoeppner SS, Goff DC, Achtyes ED, Ayer D, Schoenfeld DA. Maintenance treatment with varenicline for smoking cessation in patients with schizophrenia and bipolar disorder: a randomized clinical trial. JAMA. 2014 Jan 8;311(2):145-54. doi: 10.1001/jama.2013.285113.

  PMID: 24399553 BACKGROUND

• Evins AE, Cather C, Deckersbach T, Freudenreich O, Culhane MA, Olm-Shipman CM, Henderson DC, Schoenfeld DA, Goff DC, Rigotti NA. A double-blind placebo-controlled trial of bupropion sustained-release for smoking cessation in schizophrenia. J Clin Psychopharmacol. 2005 Jun;25(3):218-25. doi: 10.1097/01.jcp.0000162802.54076.18.

  PMID: 15876899 BACKGROUND

• Khan SS, Coresh J, Pencina MJ, Ndumele CE, Rangaswami J, Chow SL, Palaniappan LP, Sperling LS, Virani SS, Ho JE, Neeland IJ, Tuttle KR, Rajgopal Singh R, Elkind MSV, Lloyd-Jones DM; American Heart Association. Novel Prediction Equations for Absolute Risk Assessment of Total Cardiovascular Disease Incorporating Cardiovascular-Kidney-Metabolic Health: A Scientific Statement From the American Heart Association. Circulation. 2023 Dec 12;148(24):1982-2004. doi: 10.1161/CIR.0000000000001191. Epub 2023 Nov 10.

  PMID: 37947094 BACKGROUND

• Payne J, Razi S, Emery K, Quattrone W, Tardif-Douglin M. Integrating Community Health Workers (CHWs) into Health Care Organizations. J Community Health. 2017 Oct;42(5):983-990. doi: 10.1007/s10900-017-0345-4.

  PMID: 28391593 BACKGROUND

• Findley S, Matos S, Hicks A, Chang J, Reich D. Community health worker integration into the health care team accomplishes the triple aim in a patient-centered medical home: a Bronx tale. J Ambul Care Manage. 2014 Jan-Mar;37(1):82-91. doi: 10.1097/JAC.0000000000000011.

  PMID: 24309397 BACKGROUND

• Evins AE, Cather C, Maravic MC, Reyering S, Pachas GN, Thorndike AN, Levy DE, Fung V, Fischer MA, Schnitzer K, Pratt S, Fetters MD, Deeb B, Potter K, Schoenfeld DA. A Pragmatic Cluster-Randomized Trial of Provider Education and Community Health Worker Support for Tobacco Cessation. Psychiatr Serv. 2023 Apr 1;74(4):365-373. doi: 10.1176/appi.ps.20220187. Epub 2022 Nov 9.

  PMID: 36349498 BACKGROUND

• Evins AE, Cather C. Addressing Barriers to Provision of First-Line Pharmacotherapy for Tobacco Use Disorder. Psychiatr Serv. 2023 Apr 1;74(4):429-430. doi: 10.1176/appi.ps.20220467. Epub 2022 Nov 9. No abstract available.

  PMID: 36349495 BACKGROUND

• Han B, Aung TW, Volkow ND, Silveira ML, Kimmel HL, Blanco C, Compton WM. Tobacco Use, Nicotine Dependence, and Cessation Methods in US Adults With Psychosis. JAMA Netw Open. 2023 Mar 1;6(3):e234995. doi: 10.1001/jamanetworkopen.2023.4995.

  PMID: 36976558 BACKGROUND

• Olfson M, Gerhard T, Huang C, Crystal S, Stroup TS. Premature Mortality Among Adults With Schizophrenia in the United States. JAMA Psychiatry. 2015 Dec;72(12):1172-81. doi: 10.1001/jamapsychiatry.2015.1737.

  PMID: 26509694 BACKGROUND

• Cook BL, Wayne GF, Kafali EN, Liu Z, Shu C, Flores M. Trends in smoking among adults with mental illness and association between mental health treatment and smoking cessation. JAMA. 2014 Jan 8;311(2):172-82. doi: 10.1001/jama.2013.284985.

  PMID: 24399556 BACKGROUND

MeSH Terms

Conditions

Smoking; Behavior, Addictive; Tobacco Use Cessation; Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Behavior; Compulsive Behavior; Impulsive Behavior; Health Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Anne Eden Evins, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gladys Pachas, MD, MPH

CONTACT

617-643-1991; gpachas1@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 27, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2030
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)